After Initial Skepticism FDA’s Adcomm Backs Amylyx’s Amyotrophic Lateral Sclerosis Hopeful
The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted (7 yes and 2 no) that the…
Internationally Published, Head-To-Head Data From India Of Petros Pharmaceuticals’ STENDRA Tablets Reported Improvement In Erectile Function Also Showed Secondary Endpoints
Data Published in the "International Journal of Urology" Also Showed Secondary Endpoints, Such as Onset of action in 15 Minutes and Percentage of Patients Reaching Normal Erectile Function According to the
Eli Lilly Says Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Lilly’s Phase 3 Monotherapy Atopic Dermatitis Trials
New, late-breaking data show lebrikizumab responders reported long-lasting results at one year of treatment across measures of improvement in skin clearance, itch and disease extent and severity
Results suggest less
Ocuphire Pharma Announces Last Patient Completes Final Visit In ZETA-1 Phase 2b 24-Week Trial Of Oral APX3330 In Diabetic Retinopathy
Top-line Results are Expected in 4Q 2022
Interim Masked Safety Results Seen Demonstrate Favorable Safety and Tolerability Profile, Consistent with 11 Prior Trials of APX3330
Oral APX3330 has the Potential to Serve a
Amryt Receives Marketing Authorisation Approval And Orphan Drug Designation For Filsuvez In Great Britain
Amryt (NASDAQ:AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the Medical Healthcare &
Revance Announces FDA Approval of DAXXIFY For Injection, A Peptide-Formulated Neuromodulator With Long-Lasting Results
Approved label includes full 36-week efficacy data from Phase 3 SAKURA clinical program, positioning DAXXIFY™ as the first and only long-acting neuromodulator that demonstrates a median duration of six months and
Lyra Therapeutics Announces First Patient Enrolled In Pivotal ENLIGHTEN II Clinical Trial Of LYR-210 In Chronic Rhinosinusitis Patients
Lyra Therapeutics, Inc. (NASDAQ:LYRA) (the Company or Lyra), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to
Amylyx Pharmaceuticals Announced FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) ("Amylyx" or the "Company") announced today that the U.S.
Vanda Pharmaceuticals Announced Notice of Opportunity for an FDA Hearing on Supplemental New Drug Application for HETLIOZ to Treat Jet Lag Disorder
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) to treat jet lag disorder.
Important Biotech Catalysts For September 7, 2022 – End Of The Day Summary
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6…